IVDR categories for devices intended for use by lay persons (self-test) or outside a laboratory environment by healthcare professionals (near-patient).

Definition

Article 2(5) defines a device for self-testing as an IVD intended to be used by lay persons, including in home settings. Article 2(6) defines a device for near-patient testing as intended for testing performed outside a laboratory environment, generally near to or at the side of the patient, by a health professional. Classification rules and usability requirements differ, and Annex I Section 19 sets out specific information-for-use requirements.

Why it matters

Self-test devices attract additional usability engineering scrutiny under IEC 62366-1 and, in most cases, a higher risk class than the equivalent professional-use device. Instructions for use must be understandable by a lay person with the education level of the intended user.

Common pitfalls

•Assuming similar regulatory pathways for professional-use and self-test devices; self-tests generally face stricter scrutiny due to the lay user base.
•Underestimating the complexity of usability engineering for self-test devices, failing to meet the high standards required for lay person comprehension and safe use.
•Neglecting the specific information-for-use requirements in Annex I Section 19 of the IVDR, which mandates clear, understandable instructions for both categories but especially for self-tests.

Sources

Regulation (EU) 2017/746, Article 2 and Annex I Section 19 · EUR-Lex
European Commission - Medical Devices · European Commission
IMDRF Documents · IMDRF

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